This Month’s Focus: Excipients & Formulation
An introduction to self-emulsifying nutraceutical delivery systems (SENDS)
Like their counterparts in the pharmaceutical industry, many dietary ingredients are poorly soluble. This article describes how self-emulsifying nutraceutical delivery systems improve solubility and enable formulators to deliver these difficult ingredients in solid dosage form.
Control strategy considerations during formulation and process development
Control strategy is a key element of drug product development that requires understanding the product and process development, as well as the relationships among the materials, equipment, process, and facility attributes. A control strategy is required regardless of whether you undertake a traditional or Quality-by-Design approach to development.
A novel MCC for reducing segregation in direct-to-press blends
This article describes a novel MCC and presents a study in which it is shown to decrease segregation in a low-dose tablet compared to a tablet made using an industry-standard MCC.
Gemini favors plant-based excipients to propagate clean-label supplements
The company has developed more than 500 products using the alternative ingredients.
Back Page: Recent developments regarding a Novel Excipient Qualification process
The meeting with IQ and IPEC-Americas was attended by about 40 FDA staff from various offices and divisions. It was a great success.
Spotlight on Nutraceuticals: FDA draft Guidance on new dietary ingredients: Do you need to file?
Many people are wondering whether they should submit notifications for products they’ve had on the market for years. This article explains the issues and discusses steps you should take to avoid FDA action.
Excessive downtime isn’t easy to swallow
It’s impossible to prevent every episode of unscheduled downtime, but you can take steps to minimize its frequency and severity.
Alternative dosage forms
FAT of tablet presses
Capsules as a package for lipid formulations
A new taste-masking excipient
January: Capsule Filling
June: Solid Dosage Sourcebook
July: Excipients & Formulation
October: Quality, Validation & Regulatory Compliance
November: Annual Buyer’s Guide
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2. Multi-layer Tabletting
2. Powder Transfer & Containment
2. Mixers & Blenders
2. Tablet & Capsule Identification